Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name monitor, breathing frequency
510(k) Number K861423
Device Name DEMAND OXYGEN SAVER SYSTEM (D02S)
Applicant
APPLIED MEMBRANE TECHNOLOGY, INC.
11558 ENCORE CIRCLE
MINNETONKA,  MN  55343
Applicant Contact STEPHEN P CONOVER
Correspondent
APPLIED MEMBRANE TECHNOLOGY, INC.
11558 ENCORE CIRCLE
MINNETONKA,  MN  55343
Correspondent Contact STEPHEN P CONOVER
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received04/16/1986
Decision Date 05/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-